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Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1

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Conditions

Heart FailureType 2 Diabetes MellitusKetone Body MetabolismMyocardial Glucose UptakePositron Emission TomographyMyocardial Function

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To examine the effect of an increase in plasma beta-hydroxy-butyrate (B-OH-B) levels, spanning the physiologic and pharmacologic range (+0.5, +2.0, and +5.0 mmol/L), on: (i) parameters of left ventricular (LV) systolic and diastolic function utilizing cardiac magnetic resonance imaging (MRI) and (ii) myocardial glucose uptake using positron emission tomography (PET) with 18F-fluoro-2-deoxy-D-glucose in type 2 diabetic patients with Class II-III New York Heart Association (NYHA).

Official Title

Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1.

Quick Facts

Study Start:2019-01-07
Study Completion:2024-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03560323

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Type 2 diabetes.
  2. 2. Class II-III New York Heart Association (NYHA) heart failure with ejection fraction less than 50 %.
  3. 3. Age 18-80 years.
  4. 4. BMI 23-38 kg/m2.
  5. 5. HbA1c 6.0-9.0 %.
  6. 6. Blood pressure \< 145/85 mmHg.
  7. 7. eGFR \> 30 mL/min/1.73 m2.
  8. 8. NT-proBNP ≥ 500 pg/mL (or ≥ 300 pg/mL if ejection fraction is less than 35 %).
  1. 1. Treatment with Glucagon-like peptide-1 receptor agonist (GLP-1 RA), Dipeptidyl peptidase-4 inhibitors (DPP4i), pioglitazone, SGLT2 inhibitor or insulin.
  2. 2. Women who are pregnant or breastfeeding.
  3. 3. Contraindications for MRI include metal plates, parts, screws, shrapnel, pins in the body, or cardiac pacemaker.
  4. 4. Any other condition that in the opinion of the investigator create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results.

Contacts and Locations

Principal Investigator

Ralph A DeFronzo, MD
PRINCIPAL_INVESTIGATOR
UT Health San Antonio

Study Locations (Sites)

Texas Diabetes Institute - University Health System
San Antonio, Texas, 78207
United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

  • Ralph A DeFronzo, MD, PRINCIPAL_INVESTIGATOR, UT Health San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-07
Study Completion Date2024-12-30

Study Record Updates

Study Start Date2019-01-07
Study Completion Date2024-12-30

Terms related to this study

Keywords Provided by Researchers

  • Ketone Body Metabolism
  • Myocardial Glucose Uptake
  • Positron Emission Tomography
  • Myocardial Function

Additional Relevant MeSH Terms

  • Heart Failure
  • Type 2 Diabetes Mellitus